It was in 1993, just 25 years ago, that congress passed an act to require more diversity in clinical trials. Specifically, it required more female and ethnic minority representation. Since then, progress has slowly climbed for women and in 2017 we made it to 55% female participation. However, racial diversity in clinical trials is still severely lacking. Why? It’s because we’re not starting fresh. There’s a lot of oppressive history we have to account for, and quite a lot we need to address. But there are things we can do to make clinical trials more inclusive, and it starts by spreading awareness.
In addition to incredible human rights violations in various facets of life, minorities historically faced ill-treatment in the healthcare field, a problem that it still present to this day. This was, of course, under the rare circumstances when minorities were included in the medicine at all, and it certainly did not increase the desire they had to join. The most notable case of poorly treated minorities within clinical trials was called the Tuskegee Syphilis Study.
The study occurred for 40 years- from 1932 to 1972. It was led by the US Public Health Service. The goal of the study was, in essence, to learn more about syphilis; however, it was conducted in a very unethical way. They advertised free medical care for participants and recruited 600 African-American men of low socio-economic status from Alabama. 399 of these men had syphilis and 201 did not. In 1945, just about a quarter way through the trial, penicillin became a widely available treatment for syphilis. However, instead of ending the study or continuing to study participants while they improved from syphilis post-treatment, researchers withheld the drug from the dying men. They wanted to continue to study the diseases progression all the way till death. They performed autopsies on the men as they suffered and died.
Thankfully, in 1972 the study came to an end thanks to a report written by Jean Heller. $10 million in settlement was filed and new legislation was developed. The National Research Act was created to ensure more stringent oversight in research with human subjects. Informed consent, IRBs, and assurances of compliances were established to protect patients.
With this ugly history, it is unsurprising for minorities to be apprehensive about participation. And it’s on us to make amends.
Why representation is such a problem
In 2016, 79% of participants in FDA approved drug trials were white. Just 7% were black. In that year 13.4% of the US population was black. This clearly isn’t representative of our population. But why does it really matter?
Besides being, you know, completely unethical, there’s another big reason why this issue is so important in clinical trials. It’s because patients are diverse.The goal of clinical trials is to determine the efficacy of a drug in a specific patient population. If we are only investigating its effect in only part of the population, we may not be getting the whole picture. Ultimately, this could be dangerous for the minorities involved.
“Understanding the safety and efficacy of drugs for all patients hinges on the participation of diverse racial and ethnic subgroups. One size does not fit all when it comes to drugs.”
Not only may efficacy of a drug be different within different populations, side effects and toxicities may represent themselves differently. Often, it’s related to how different genetic makeups metabolize drugs. Currently, 20% of drugs are prescribed at different dosages depending on the ethnicity of the patient. For instance, Asian patients with thrombocytopenia
are only given half of the typical treatment dose. This is due to their increased risk of side effects.
Some cancers also have a different driver in different patient populations. Even if the treatment metabolizes the same in all patients, the disease itself may need to be treated differently depending on how it presents itself in different individuals. The chance of an ethnic minority developing a certain illness might be greater than other populations. White men have a 10% chance of developing prostate cancer, whereas black men have a 15% chance. Black men diagnosed with prostate cancer also have a mortality rate which is twice as high as white men because they are more frequently diagnosed at its more aggressive stage. Clinical trials still fail to address this obvious need.
So what can we do?
We can raise awareness about the importance of clinical trials, upcoming clinical trials, and the safety which now exists for trials. We need to work to ensure that minority populations receive these messages. To accomplish this, we need to meet minority populations where they are. We must work to understand their apprehensions and spread knowledge of current practices.
Project CHURCH is a Houston-based program aiming to address the health disparities present within the African-American community. The goal is to first understand what factors (socioeconomic, lifestyle, and environmental) put African-Americans at a higher risk for developing cancer. In order to do so, they’ve created a community between 2,500 churchgoers in Houston in an effort to raise awareness about clinical trials and the potential benefits of clinical trials.
They’re necessary for progress in the medical field, and minorities deserve the same amount of progress as anyone else.
“Ultimately, everyone should have access to good quality medical care and clinical trials are part of that.”
You can read more about this story here.